A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

It had two arms (groups): LY2963016 (experimental) and LANTUS® (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 493 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have type 2 diabetes mellitus (T2DM). If currently on basal insulin, must be taking LANTUS® QD or NPH or insulin detemir either QD or twice a day for at least 90 days prior to study entry. Body mass index (BMI) ≤45 kilograms per meter squared (kg/m\^2). As determined by the investigator, are capable and willing to do the following:. Perform self monitored blood glucose (SMBG).

The full record lists 10 inclusion and 23 exclusion criteria; among the exclusions: have been on lantus® more than once daily within the previous 30 days; have been exposed to a biosimilar insulin glargine within the previous 90 days; have participated in a ly2963016 study.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2014-12 with completion listed for 2016-07.

It ran at 44 sites in India (11), United States (10), South Korea (9), Taiwan (5), Turkey (Türkiye) (4) and Russia (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, 24 weeks).

It also tracked 10 secondary outcomes, for example Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values, Intra-Participant Variability in Fasting Blood Glucose (FBG), Change From Baseline to 24 Weeks in Body Weight, Insulin Treatment Satisfaction Questionnaire (ITSQ) Score, Percentage of Participants With Detectable Anti-Drug Antibodies to LY2963016 or LANTUS® and Rate of Hypoglycemic Events Adjusted Per 1 Year.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 493 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page, all human trials.